NDC 43353-072

Tramadol Hydrochloride

Tramadol Hydrochloride

Tramadol Hydrochloride is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Tramadol Hydrochloride.

Product ID43353-072_5e1836c1-7b36-4ea5-8fa2-87e8d8d6b21f
NDC43353-072
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride
Generic NameTramadol Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2010-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA076003
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-072-89

720 TABLET, COATED in 1 BOTTLE, PLASTIC (43353-072-89)
Marketing Start Date2010-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-072-72 [43353007272]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-57 [43353007257]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-24 [43353007224]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-92 [43353007292]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-46 [43353007246]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-80 [43353007280]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-54 [43353007254]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-75 [43353007275]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-98 [43353007298]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-73 [43353007273]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-20 [43353007220]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-94 [43353007294]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-89 [43353007289]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-65 [43353007265]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-67 [43353007267]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-60 [43353007260]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-53 [43353007253]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-30 [43353007230]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-45 [43353007245]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-90 [43353007290]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-40 [43353007240]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-15 [43353007215]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-85 [43353007285]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-28 [43353007228]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-70 [43353007270]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 43353-072-50 [43353007250]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

NDC 43353-072-48 [43353007248]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:648d4e25-d72d-4434-b5fe-119b6c586afe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835603

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Tramadol Hydrochloride" or generic name "Tramadol Hydrochloride"

    NDCBrand NameGeneric Name
    0093-0058Tramadol HydrochlorideTramadol Hydrochloride
    0378-4151Tramadol Hydrochloridetramadol hydrochloride
    0378-4152Tramadol Hydrochloridetramadol hydrochloride
    0378-4153Tramadol Hydrochloridetramadol hydrochloride
    0378-4154Tramadol Hydrochloridetramadol hydrochloride
    0615-7810Tramadol Hydrochloridetramadol hydrochloride
    0615-8005Tramadol HydrochlorideTramadol Hydrochloride
    0904-6365TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    0904-7179tramadol hydrochloridetramadol hydrochloride
    10147-0901TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    10147-0902TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    10147-0903TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    10370-221Tramadol Hydrochloridetramadol hydrochloride
    10370-222Tramadol HydrochlorideTramadol Hydrochloride
    10370-223Tramadol HydrochlorideTramadol Hydrochloride
    10544-009Tramadol HydrochlorideTramadol Hydrochloride
    10544-531Tramadol HydrochlorideTramadol Hydrochloride
    12634-786TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-3280TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-1978Tramadol HydrochlorideTramadol Hydrochloride
    68071-3321TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4119Tramadol HydrochlorideTramadol Hydrochloride
    68071-4165TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4154TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4070TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4282tramadol hydrochloridetramadol hydrochloride
    68084-808Tramadol HydrochlorideTramadol Hydrochloride
    68071-4802tramadol hydrochloridetramadol hydrochloride
    68094-017Tramadol HydrochlorideTramadol Hydrochloride
    68180-698TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68180-699TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68180-697TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68258-2003TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68382-319TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68387-900Tramadol HydrochlorideTramadol Hydrochloride
    68788-7321tramadol hydrochloridetramadol hydrochloride
    68788-9199Tramadol HydrochlorideTramadol Hydrochloride
    68788-6929TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-8921TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-7284Tramadol HydrochlorideTramadol Hydrochloride
    68788-7373TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-8920Tramadol HydrochlorideTramadol Hydrochloride
    68788-9232TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-9237TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    69150-020Tramadol HydrochlorideTramadol Hydrochloride
    69420-5150Tramadol HydrochlorideTramadol Hydrochloride
    69467-1001Tramadol HydrochlorideTramadol Hydrochloride
    69543-136Tramadol HydrochlorideTramadol Hydrochloride
    69677-316Tramadol HydrochlorideTramadol Hydrochloride
    70518-0054Tramadol HydrochlorideTramadol Hydrochloride
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